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Comparative Study
. 2019 Dec 1;5(12):1769-1773.
doi: 10.1001/jamaoncol.2019.2055.

Factors Associated With Age Disparities Among Cancer Clinical Trial Participants

Ethan B Ludmir  1 , Walker Mainwaring  2 , Timothy A Lin  1   2 , Austin B Miller  3 , Amit Jethanandani  1   4 , Andres F Espinoza  2 , Jacob J Mandel  2 , Steven H Lin  1 , Benjamin D Smith  1 , Grace L Smith  1 , Noam A VanderWalde  4 , Bruce D Minsky  1 , Albert C Koong  1 , Thomas E Stinchcombe  5 , Reshma Jagsi  6 , Daniel R Gomez  1   7 , Charles R Thomas Jr  8   9 , C David Fuller  1
Affiliations
Comparative Study

Factors Associated With Age Disparities Among Cancer Clinical Trial Participants

Ethan B Ludmir et al. JAMA Oncol. .

Abstract

Importance: Seminal investigation 2 decades ago alerted the oncology community to age disparities in participation in cooperative group trials; less is known about whether these disparities persist in industry-funded research.

Objective: To characterize the age disparities among trial enrollees on randomized clinical trials (RCTs) of common cancers in clinical oncology and identify factors associated with wider age imbalances.

Data sources: Phase 3 clinical oncology RCTs were identified through ClinicalTrials.gov.

Study selection: Multiarm RCTs assessing a therapeutic intervention for patients with breast, prostate, colorectal, or lung cancer (the 4 most common cancer disease sites) were included.

Data extraction and synthesis: Trial data were extracted from ClinicalTrials.gov. Trial screening and parameter identification were independently performed by 2 individuals. Data were analyzed in 2018.

Main outcomes and measures: The difference in median age (DMA) between the trial participant median age and the population-based disease-site-specific median age was determined for each trial.

Results: Three hundred two trials met inclusion criteria. The trials collectively enrolled 262 354 participants; 249 trials (82.5%) were industry-funded. For all trials, the trial median age of trial participants was a mean of 6.49 years younger than the population median age (95% CI, -7.17 to -5.81 years; P < .001). Age disparities were heightened among industry-funded trials compared with non-industry-funded trials (mean DMA, -6.84 vs -4.72 years; P = .002). Enrollment criteria restrictions based on performance status or age cutoffs were associated with age disparities; however, industry-funded trials were not more likely to use these enrollment restrictions than non-industry-funded trials. Age disparities were also larger among trials that evaluated a targeted systemic therapy and among lung cancer trials. Linear regression modeling revealed a widening gap between trial and population median ages over time at a rate of -0.19 years annually (95% CI, -0.37 to -0.01 years; P = .04).

Conclusions and relevance: Age disparities between trial participants and the incident disease population are pervasive across trials and appear to be increasing over time. Industry sponsorship of trials is associated with heightened age imbalances among trial participants. With an increasing role of industry funding among cancer trials, efforts to understand and address age disparities are necessary to ensure generalizability of trial results as well as equity in trial access.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr S. Lin reported grants from Genentech, New River Labs, Beyond Spring Pharmaceuticals, and Hitachi Chemical Diagnostics and other support from AstraZeneca Inc outside the submitted work. Dr Smith reported other support from Oncora Medical outside the submitted work. Dr Vanderwalde reported other support from Vector Oncology/Concerta AI outside the submitted work. Dr Koong reported stock ownership in Aravive Inc. Dr Stinchcombe reported grants and personal fees from Takeda and AstraZeneca; personal fees from Novartis and G1 therapeutics; and grants and personal fees from Genentech/Roche outside the submitted work. Dr Jagsi reported grants from the National Institutes of Health, Doris Duke Charitable Foundation, Komen Foundation, and Blue Cross Blue Shield of Michigan for the Michigan Radiation Oncology Quality Consortium; grants and personal fees from Greenwall Foundation; personal fees from Vizient and Amgen; and other support from Equity Quotient outside the submitted work. Dr Gomez reported grants and personal fees from Varian, AstraZeneca, BMS, and Merck and personal fees from US Oncology, Reflexion, WebMD, Vindico, and Medscape outside the submitted work. Dr Fuller reported grants and personal fees from Elekta AB outside the submitted work and the Andrew Sabin Family Foundation during the conduct of the study; he is also a Sabin Family Foundation Fellow. Dr Fuller receives funding and salary support from the National Institutes of Health, including the National Institute for Dental and Craniofacial Research Establishing Outcome Measures Award (1R01DE025248/R56DE025248) and an Academic Industrial Partnership Grant (R01DE028290); a National Science Foundation Division of Mathematical Sciences, Joint National Institutes of Health/National Science Foundation Initiative on Quantitative Approaches to Biomedical Big Data grant (NSF 1557679); a National Institute of Biomedical Imaging and Bioengineering Research Education Programs for Residents and Clinical Fellows grant (R25EB025787-01); the National Institutes of Health Big Data to Knowledge Program of the National Cancer Institute Early Stage Development of Technologies in Biomedical Computing, Informatics, and Big Data Science Award (1R01CA214825); National Cancer Institute Early Phase Clinical Trials in Imaging and Image-Guided Interventions Program (1R01CA218148); an National Institutes of Health/National Cancer Institute Cancer Center Support Grant Pilot Research Program Award from the UT MD Anderson CCSG Radiation Oncology and Cancer Imaging Program (P30CA016672) and an National Institutes of Health/National Cancer Institute Head and Neck Specialized Programs of Research Excellence Developmental Research Program Award (P50 CA097007. Dr Fuller has also received direct industry grant support, honoraria, and travel funding from Elekta AB. No other disclosures were reported.

Figures

Figure.
Figure.. Flowchart of Clinical Trial Screening, Eligibility, and Inclusion
BPCRL indicates breast/prostate/colorectal/lung cancer; RCTs, randomized clinical trials.
See this image and copyright information in PMC

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